FDA Approvals

MONDAY, May 21, 2018 -- Doptelet (avatrombopag) has been approved by the U.S. Food and Drug Administration to treat adults with chronic liver disease who are slated to have a medical or dental procedure.

People with ongoing liver disease often have low blood platelet count, which raises their risk for dangerous bleeding during a medical procedure, the agency said Monday in a news release.

FRIDAY, May 18, 2018 -- Aimovig (erenumab-aooe) has been approved by the U.S. Food and Drug Administration to prevent migraine headaches in adults.

Aimovig is the first FDA-approved preventive migraine treatment in a new class of drugs that work by blocking the activity of calcitonin gene-related peptide, a molecule involved in migraine attacks, the agency said in a news release.

TUESDAY, May 15, 2018 -- Retacrit (epoetin alfa-epbx) has been approved by the U.S. Food and Drug Administration as the first "biosimilar" to the anemia drugs Epogen and Procrit.

A biosimilar, derived from a living organism, has been proven to be "highly similar" to a product that's already been approved by the FDA. It's also been shown to have no "clinically meaningful differences" in its safety, purity and potency than the prior approved drugs, the agency explained Tuesday in a news release.

MONDAY, May 7, 2018 -- The U.S. Food and Drug Administration has approved the new Hemospray device to help control bleeding of the gastrointestinal tract.

Bleeding in the stomach, intestines, colon or rectum may be caused by factors such as ulcers, malformed blood vessels, diverticulosis, cancer or inflammatory bowel disease, the FDA explained in a news release Monday.

TUESDAY, April 10, 2018 -- The U.S. Food and Drug Administration has approved the first contact lenses that automatically darken in bright light, the agency said Tuesday in a news release.

The technology, used for years in eyeglasses, stems from an additive that's added to the lenses, which then react to the sun's ultraviolet rays. The Acuvue Oasys lenses return to their normal tint when the user moves to normal or darker lighting.

THURSDAY, March 29, 2018 -- The U.S. Food and Drug Administration says it has expanded approval for Blincyto (blinatumomab) to include adults and children with B-cell precursor acute lymphoblastic leukemia who are in remission but who still have minimal residual disease (MRD).

MRD describes the presence of cancer cells in the body, but below levels that can be seen in a microscope, the agency said Thursday in a news release. This condition raises a person's chances that the cancer will come back.

TUESDAY, March 20, 2018 -- U.S. Food and Drug Administration approval of Adcetris (brentuximab vedotin) has been expanded to include adults with untreated stage III or IV classical Hodgkin lymphoma, the agency said Tuesday in a news release.

The drug was first approved to treat Hodgkin lymphoma in 2011 and has been granted a number of additional approvals.